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Bayer submits an IND for its MN-IC antibody-drug conjugate to the FDA

Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that it has achieved a milestone under its antibody-drug conjugate (ADC) collaboration with Bayer Schering Pharma AG, Germany. The milestone was triggered by Bayer’s submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for MN-IC, an ADC for solid tumors.

9 Sep 2009

Maxim Health to launch its annual influenza vaccination program on October 1

It is the start of the flu season and with seasonal influenza responsible for more than 36,000 deaths per year, getting a flu vaccine is critical. Today, Maxim Health Systems announced on October 1 it will launch its annual influenza vaccination program and will provide flu shots nationwide through more than 44,000 clinics.

9 Sep 2009

PacifiCord and Milkalicious to sponsor a debate on pediatric vaccines

Dedicated to serving the private cord blood banking needs of Southern California, PacifiCord (www.pacificord.com) announced they are partnering with Milkalicious, an Aliso Viejo-based breastfeeding boutique and education center, in sponsoring “The Great Vaccine Debate.”

9 Sep 2009

FDA approves Salix' METOZOLV ODT for treating diabetic gastroparesis

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the U.S. Food and Drug Administration (FDA) has granted marketing approval for METOZOLV™ ODT (metoclopramide HCl) 5mg and 10mg orally disintegrating tablets. METOZOLV ODT is indicated for the relief of symptoms in adults associated with acute and recurrent diabetic gastroparesis and for the treatment of short-term therapy (4-12 weeks) for adults with symptomatic documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy1.

9 Sep 2009

Gabapentin improves sleep quality in menopausal women

Gabapentin, a drug initially used to treat seizures, improves sleep quality in menopausal women with hot flashes, University of Rochester Medical Center researchers report online and in the September issue of the Journal of Women's Health.

9 Sep 2009

Laureate Pharma and Neoprobe sign manufacturing agreement

Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, and Laureate Pharma, Inc., a full-service biopharmaceutical development and protein production company, today announced that they have entered into a Biopharmaceutical Development and Manufacturing Agreement.

9 Sep 2009

BioElectronics to file for FDA pre-marketing clearance of its ActiPatch Therapy product

BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, today announces its schedule for filing with the U.S. government's Food and Drug Administration for 510(K) pre-marketing clearance for its ActiPatch® Therapy and RecoveryRx™ products. In these applications BioElectronics will seek over-the-counter clearance of its ActiPatch Therapy product for indications for the treatment of heel and foot pain, and for pain relief relative to general musculoskeletal complaints.

9 Sep 2009

Sinovac's first lot of H1N1 vaccine released by China's NICPBP

Sinovac Biotech Ltd. (NYSE Amex: SVA), a leading provider of vaccines in China, today announced that the first lot of PANFLU.1, its H1N1 vaccine, has passed the lot release process of China's National Institute for the Control of Pharmaceutical and Biological Products and obtained the Certificate for the Release of Biological Products, which means the released vaccines are ready for delivery.

9 Sep 2009

Care-Tech Laboratories consents to end illegal manufacture and marketing of OTC drugs

The U.S. Food and Drug Administration today announced that St. Louis-based Care-Tech Laboratories Inc. and its principal officers, John C. Brereton and Sherry L. Brereton, have signed a consent decree, agreeing to stop the illegal manufacture, marketing, and distribution of over-the-counter (OTC) antimicrobial drugs used to treat and prevent infection.

9 Sep 2009

Rice researchers describe a new method to predict the efficacy of H1N1 vaccines

As manufacturers work furiously to make a vaccine to protect against 2009 influenza A (H1N1) virus, a Rice University bioengineer is trying to improve the process for future flu seasons. The goal is to shorten the time it takes to identify targeted flu strains and manufacture the vaccines for them.

9 Sep 2009

Meda launches EDLUAR in the U.S.

Meda Pharmaceuticals Inc. (Meda) today announced the commercial availability of EDLUAR(TM) (zolpidem tartrate sublingual tablets) in the United States. EDLUAR is indicated for the short-term treatment of insomnia characterized by difficulties with falling asleep. EDLUAR is the first available under-the-tongue formulation of zolpidem tartrate, which is the most prescribed treatment for insomnia. Zolpidem tartrate is also the active ingredient in Ambien(R) oral tablets.

9 Sep 2009

Space-age technology to combat counterfeit pharmaceuticals

University of Leicester researchers have combined crime research and space-age technology in ways that could lead to the quick detection of counterfeit pharmaceuticals in a black market currently worth an estimated $40billion per year.

9 Sep 2009

China Sky's Pain Relief patches enters Canadian market

China Sky One Medical, Inc. ("China Sky One Medical" or "the Company") (Nasdaq: CSKI), a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China ("PRC"), today announced that the Company has begun to export its Pain Relief patch to Canada. The first order included 40,000 patches, which are now available in some stores and supermarkets in Vancouver.

9 Sep 2009

Teva Pharmaceutical Industries to present MS treatment research data

Teva Pharmaceutical Industries Ltd. today announced that new research data furthering the clinical understanding of its diverse multiple sclerosis (MS) treatment franchise will be presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Düsseldorf, Germany, September 9-12, 2009.

9 Sep 2009

NIH awards Vaxart $2.8M grant to develop an orally-delivered H5N1 Avian influenza vaccine

Vaxart, Inc., a San Francisco biotechnology company developing oral-delivery vaccines, has been awarded a $2.8 million phase II Small Business Innovation Research grant from the National Institute of Allergy and Infectious Disease (National Institutes of Health) to support development of its first product, an orally-delivered vaccine for H5N1 Avian influenza.

9 Sep 2009

GENova Biotherapeutics files patent for Prostaganin anti-cancer drug

GENova Biotherapeutics, Inc., ("GENova"), is pleased to announce that it has filed a patent for a novel peptide that disrupts the advance of prostate cancer and thus has blockbuster potential as a new anti-cancer drug.

9 Sep 2009

FDA approves ISTA's Bepreve for treating ocular itch

ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) today announced the U.S. Food and Drug Administration (FDA) has approved Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% as a twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older.

9 Sep 2009

Cytrx to submit revised protocol for arimoclomol Phase IIb clinical trial

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, today announced its intention during the 2009 fourth quarter to submit a revised protocol for its planned Phase IIb clinical trial for arimoclomol as a treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The decision follows receipt of an anticipated written letter from the U.S.

8 Sep 2009

KRYSTEXXA development and treatment failure gout to be presented

Savient Pharmaceuticals, Inc. announced that five abstracts relating to KRYSTEXXA (pegloticase) development and treatment failure gout will be presented at the 2009 ACR/ARHP Annual Scientific Meeting taking place in Philadelphia from October 16-21, 2009.

8 Sep 2009

FDA undecided on safety guidelines for hydroquinone use

According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the US market for physician-dispensed cosmeceutical pigment control products will experience considerable growth in sales over the next five years. MRG's US Markets for Physician-Dispensed Cosmeceuticals 2009 report finds, however, that product safety issues involving hydroquinone, the active ingredient in many pigment control products, have led the Food and Drug Administration (FDA) to second guess the use of the compound in such products.

8 Sep 2009